Interactive medication delivery system

ABSTRACT

A medication delivery device includes a housing containing separate first and second storage locations for holding medication dosages away from access by the user. Associated separate first and second delivery mechanisms permit selective delivery of a medication dose from either the first or second storage locations to the patient. The invention provides a control element that discriminates between the actuation of the first delivery mechanism and the second delivery mechanism, thereby discriminating between the delivery of medication housed in the first and second storage locations. The control element discriminates between different first and second input criteria. In response to the first input criteria but not in response to the second input criteria, the control element actuates the first delivery mechanism. In response to the second input criteria, the control element actuates the second delivery mechanism.

This is a continuation of copending application Ser. No. 7/415,172 filedon Sep. 28, 1989.

FIELD OF THE INVENTION

The invention generally relates to systems for dispensing medications.In a more particular sense, the invention concerns systems which overseeand coordinate the administration of complex medication regimens athome, outside the support system of a hospital or pharmacy, and withoutthe day to day supervision of medical personnel. In this more particularsense, the invention also concerns automated home care patient healthmonitoring systems.

BACKGROUND OF THE INVENTION

Due to advances in medicine and medical treatments in general, peopleare living longer. As a result, the number and percentage of olderpeople are growing in the United States and elsewhere.

However, despite medical advances, many elderly people still facechronic and debilitating health problems. Arthritis, hypertension, andheart conditions are but a few examples of the problems associated withlongevity.

Treatment of these health problems often requires close compliance withrelatively complex medication regimes. It is not unusual for a personhaving one of the above health problems to be taking four or moredifferent prescription drugs at one time. These drugs often differsignificantly in dosages, both as to time and amount, as well as intheir intended physiological effects. These drugs also often differ inthe severity of potentially adverse reactions due to mismedication.

Close and careful compliance with these complex medication regimes is adifficult task in itself. The difficulty is greatly enhanced,considering that the - elderly must discipline themselves to followthese regimes at home, without the day-to-day support and supervision oftrained hospital and pharmacy personnel, and often without theday-to-day support and supervision of their immediate families or othercaregivers. Furthermore, a loss in short term memory can be naturallyattributed to the aging process and to the medication themselves,resulting in forgetfulness and further confusion in schedulingcompliance with complicated medication regimes.

The elderly are therefore increasingly at risk of hospitalization ordeath from mismedication.

An interactive patient assistance device, ideally suited to the needs ofhome care patients--young and old alike--is described in Kaufman et al.U.S. patent application No. 201,779 (filed Jun. 2, 1988)now U.S. Pat.No. 4,933,873. The device includes a self-contained medication deliverymechanism and self-contained physical testing apparatus. The devicenormally retains the medication and the testing apparatus away fromaccess by the patient. Both medication and the testing apparatus aremade available to the patient, either in response to a prescribedschedule or in response to a verbal command made by the patient.

The present invention enhances and expands the flexible, interactivesystem described in the Kaufman et al. application.

The invention is directed to improving the overall well-being andlifestyle of home care patients who are on complicated medicationregimes. The invention addresses the problems of compliance with acomplicated regime of differing medications and solves these problems byproviding a reasonable degree of self-sufficiency and personal controlover the administration of medication without sacrificing the overalltherapeutic objectives of the prescribed medical treatment.

SUMMARY OF THE INVENTION

The invention provides an interactive medication delivery device thatdiscriminates, within a given medication regime, between differentcategories of medication and different schedules of medicationadministration. The invention provides a device that can administermedication differently, realizing that a given treatment regime ofteninvolves the administration of altogether different types of medication.The invention provides a significant degree of flexibility that permitsa patient to exercise greater personal control over the administrationof his or her medication. However, at the same time, the inventionassures strict adherence to a prescribed medication regime.

The medication delivery device that embodies the features of theinvention includes a housing containing separate first and secondstorage locations for holding medication dosages away from access by thepatient. Associated separate first and second delivery mechanisms permitselective delivery of a medication dose from either the first or secondstorage locations to the patient. The invention provides a controlelement that discriminates between the criteria for actuating the firstdelivery mechanism and the criteria for actuating the second deliverymechanism. The control element thereby discriminates between thedelivery of medication housed in the first and second storage locations.

In one aspect of the invention, the different input criteriadiscriminate between one category of medication that can be onlyadministered according to a prescribed schedule and another category ofmedication that can be safely administered upon demand. In this aspect,the control element includes internal memory for storing the prescribedmedication administration schedule, as well as an external input devicefor receiving and interpreting at least one prescribed medicationdelivery command from the patient. In this arrangement, the controlelement actuates the first delivery mechanism in response to theprescribed schedule stored in the internal memory, but it will notactuate the first delivery mechanism in response to the receipt of amedication delivery command from the external input device. Themedication that is to be administered only in response to the prescribedschedule can thereby be placed in the first storage location, and thedevice will assure compliance by delivering it to the patient only inaccordance with the schedule. However, the control element will actuatethe second delivery mechanism in response to the receipt of a prescribedmedication delivery command from the patient via the external inputdevice. The medication that can be delivered upon patient demand canthereby be placed in the second storage location, separate from theother, more strictly controlled medication. The control element willallow the patient access to the permitted "on demand" medication,without otherwise jeopardizing the rest of the patient's medicationregime.

In another aspect of the invention, the different input criteriadiscriminate between categories of medication that are administeredaccording to different prescribed schedules. In this arrangement, thecontrol element actuates the first delivery mechanism in response to afirst prescribed schedule, but not in response to a second prescribedschedule. The control element responds to the second prescribed scheduleto actuate the second delivery mechanism.

In one embodiment of this arrangement, the control element includes anexternal input for receiving and interpreting at least one prescribedmedication delivery command from the patient, as before described. Inthis embodiment, control element actuates the first delivery mechanismas before described, in response to the first prescribed schedule, butnot in response to either the second prescribed schedule or themedication delivery command from the external input. However, controlelement will actuate the second delivery mechanism not only in responseto the second prescribed schedule but also in response to a prescribedmedication delivery command from the external input. Therefore, theinvention will flexibly accommodate a medication that is be administeredin accordance with a schedule, but that can also be administered upondemand by the patient.

In another aspect of the invention, the different input criteriadiscriminate between one category of medication that can be onlyadministered according to the schedule prescribed by the physician andanother category of medication that can or should be administered whenthe then-existing health parameters of the patient dictate.

In this arrangement, the control element includes internal memory forstoring the prescribed schedule for administering medication. Thecontrol element also includes external input apparatus for receiving andinterpreting information indicative of selected one or more healthparameters of the patient. In this arrangement, the first deliverymechanism is actuated in response to the prescribed schedule, but not inresponse to the receipt of information by the external input apparatus.On the other hand, the control element will actuate the second deliverymechanism in response to the receipt and interpretation of healthparameter information by the external input apparatus.

In one embodiment of this arrangement, the device includes an externaloutput for prompting preselected information of a qualitative naturefrom the patient. The device also includes an input for receiving andinterpreting responses made by the patient to the prompting of theexternal output. The associated external input apparatus includestesting apparatus for the patient to quantitatively measure apreselected physical parameter. The control element correlates thequantitative measurement by the testing apparatus with the qualitativeresponses received and generates a control signal to actuate the seconddelivery mechanism when a predetermined correlation is found to exist.

In a preferred embodiment of the invention, the control element includesa timer for preventing a second actuation of the second deliverymechanism, despite the receipt of an otherwise proper actuating command,when the time period between a first and second actuation is less than aprescribed period. The risk of mismedication of on demand-typemedication is thereby minimized.

Also in a preferred embodiment, the external input includes a speechrecognition device for receiving and interpreting at least oneprescribed verbal command made by the patient. In this arrangement, thedevice also preferably includes a speech output apparatus for generatingaudible messages to the patient. The personal, interactive nature of thedevice is thereby enhanced.

In accordance with the invention, the device may also include amechanism for altering a prescribed medication schedule in response tothe receipt of a prescribed change schedule command from the physicianor user.

In another aspect, the invention further provides a system that operatesin response to the command signals generated by the control element formaintaining a data file for each medication dispensing device. The datafile includes one or more records reflecting information of use forinventory control and management purposes.

The invention provides a device that can oversee and administer arelatively complex regime of different types of medication in a flexibleand user-friendly manner. By integrating relatively unyieldingcompliance to a prescribed schedule for certain medication with anaccommodating approach to other types of medication, the inventionprovides the patient with an automated caregiver that is strict incertain respects but responsive in others.

Other features and advantages of the invention will become apparent uponreviewing the following detailed description, drawings, and appendedclaims.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a front perspective view of a patient monitoring andassistance device having an enclosed system for delivering physicaltesting devices to the patient, as well as an enclosed medicationstorage and dispensing system that embodies the features of theinvention for storing and dispensing medication in individual caplets,each of Which systems is shown in its closed position;

FIG. 2 is a front perspective view of the device shown in FIG. 1, withthe testing device delivery system and medication delivery system eachshown in its open position;

FIG. 3 is an enlarged perspective view, with portions broken away, ofthe interior of the device shown in FIG. 2, showing the enclosedmedication storage and dispensing system;

FIGS. 4a and 4b (which will be collectively referred to as FIG. 4)together comprise a schematic block diagram of the system that controlsthe operation of the patient assist device shown in FIG. 1;

FIG. 5 is a schematic and partially diagrammatic block diagram of theelements of the system shown in FIG. 4 that control the operation of themedication delivery system that incorporates the invention;

FIGS. 6a, 6b, 7a, 7b, 8a, 8b, 8c, 9a and 9b are schematic and partiallydiagrammatic flow charts of differing embodiments of the system forcontrolling the operation of the medication delivery system thatincorporate aspects of the invention:

FIG. 10 is an enlarged side view, partially broken away, of themedication delivery system shown in FIG. 3, tipped outwardly from teerear of the associated patient assist device for replenishment ofmedication;

FIG. 11 is an enlarged side view, partially broken away, of themedication delivery system shown in FIG. 3 in its operative positionwithin the associated patient assist device;

FIGS. 12 to 15 are enlarged side views of the medication delivery systemtaken generally along line 12--12 in FIG. 3, showing the sequence ofoperation in dispensing medication in caplet form;

FIG. 16 is a perspective view of the medication delivery system shown inFIG. 3 as it is being replenished;

FIG. 17 is a schematic and partially diagrammatic view of a medicationinventory and management system that embodies the features of theinvention;

FIG. 18 is a schematic and partially diagrammatic view of medicationfiles contained in the inventory and management system shown in FIG. 15;and

FIG. 19 is a schematic and partially diagrammatic flow chart of amedication administration follow up sequence that forms a part of theinventory and management system shown in FIG. 15.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

One preferred embodiment of an interactive monitoring and assistancedevice 10 is shown in FIGS. 1 and 2. As will soon be described ingreater detail, the device 10 performs as a self-contained,microprocessor-based caregiver who, in a friendly and supportive manner,monitors, manages and assists a patient in performing everyday healthmaintenance tasks. In carrying out its tasks, the device 10 monitors thepatient's vital signs. The device 10 also stores and administersmedication. The device 10 preferably is linked to a central facilitythat provides round-the-clock supervision and response as required.

The device 10 includes a housing or cabinet 12 that, in a preferreddesign, stands about four feet tall. Preferably, the housing 12 isportable. For this purpose, the device 10 includes wheels 14 and ahandle 16 for the patient, or another user, to guide the movement.

As shown in FIGS. 1 and 2, the device 10 houses a system 18 for storingand delivering one or more devices for testing the vital signals of apatient. The device 10 also houses a system 20 for storing andadministering medication (see FIG. 3 also).

In the illustrated and preferred embodiment shown in FIG. 4, the device10 houses a main microprocessor-based CPU 22 that coordinates andcontrols its operation. While various arrangements are possible, the CPU22 preferably comprises an IBM PC compatible CPU board that accommodatesmulti-tasking sequences. Various input/output (I/0) devices communicatewith the main CPU 22 through conventional data and address busses 24.The I/0 devices will be described in greater detail later. A massstorage device 26 for storing digital information also communicates withthe main CPU 22 through the busses 24.

In use, as shown in FIG. 4, the device 10 is preferably linked with acentral monitoring facility 28 by a modem 30 that communicates with themain CPU 22 through the busses 24. Health care professionals are presenton a twenty-four hour basis at the central facility 28 to monitor thehealth of the patient based upon information collected and transmittedto them by the device 10. The device 10 is also preferably linked viathe modem 30 with selected individuals 32--typically close friends,family members, or other designated caregivers--who are automaticallynotified by the device 10 when certain health conditions exist or uponrequest by the patient or central facility 28. As can be seen, thedevice 10 is a central part of an overall support system for thepatient.

As shown in FIG. 2, the system 18 for monitoring the patient's vitalsigns includes two physical testing devices: a pressure cuff 34 formeasuring blood pressure and pulse rate, and a thermometer 36 formeasuring body temperature. Of course, other testing devices could beprovided, depending upon the health condition of the patient and mode oftreatment. As used in this Specification, the term "physical test"broadly includes tests of body functions (pulse, respiration,temperature, etc.) and tests of body fluids (blood, urine, saliva, etc.)by noninvasive and invasive techniques, including ultrasonic andradiographic methods.

As shown in FIG. 4, the testing devices 34 and 36 communicate with themain CPU 22 through the busses 24. The measurements taken are stored inthe data storage device 26. These measurements are also periodicallytransmitted to the central monitoring facility 28 by the modem 30. Thecentral facility 28 also preferably records received information in itsown mass storage device for record keeping, retrieval and analysis.

Preferably, the testing devices 34 and 36 are housed in a movablecompartment or drawer 38 within the housing 12. The drawer 38 isnormally closed (as shown in FIG. 1), thereby retaining the testingdevices 34 and 36 within the housing 12 away from access by the patient.The drawer 38 will open in response to an appropriate command signalreceived and interpreted by the main CPU 22. The opened position for thedrawer 38 is shown in FIG. 2. The testing devices 34 and 36 are therebymade available for use by the patient. This particular operation will bedescribed in greater detail later.

The medication delivery system 20 housed within the device 10 (see FIG.3) embodies the features of the invention. The system 20 is capable ofstoring and administering different types of medications havingdifferent administration criteria. The criteria can differ in terms ofprescribed dosage amount, prescribed frequency of administration, degreeof accessibility to the patient, or various combinations of the above.

The medication delivery system 20 includes at least two discrete storagecompartments or cassettes (generally designated 40 and 42 in FIG. 3)within the housing 12. Each storage compartment 40 and 42 is separateand self-contained. Each compartment 40 and 42 is capable ofindependently storing at least one dose of a medication 44 within thehousing 12 away from access by the user.

The medication delivery system 20 further includes independent deliverymeans or mechanisms associated with each storage compartment 40 and 42.In the illustrated arrangement (see FIGS. 3 and 5), a first deliverymechanism 46 is associated with the first storage compartment 40 forselectively delivering a medication dose from there to the patient. Asecond delivery mechanism 48 is likewise associated with the secondstorage compartment 42 for selectively delivering a medication dose fromthere to patient.

The number of individual delivery systems provided corresponds with thenumber of individual medication storage compartments. The number ofstorage compartments can, of course, vary. Only two storage compartmentsand their associated delivery systems will be discussed.

The first and second delivery mechanisms 46 and 48 operate independentlyand in response to different administration criteria. For this purpose(in particular, see FIG. 5), the medication delivery system 20 includesa control means or element 50 associated with the first and seconddelivery mechanisms 46 and 48. In the illustrated and preferredembodiment, the control element 50 communicates with the main CPU 22(see FIG. 4, too), either in the form of programmable random accessmemory (RAM) or as preprogrammed read only memory (ROM).

According to its programming, the control element 50 is capable ofreceiving and differentiating between at least two different prescribedinputs. Upon the receipt and interpretation a first prescribed input orcombination of inputs, the control element 50 will generate a controlsignal 52 that actuates the first delivery mechanism 46. Upon receipt ofthe second prescribed input or combination of inputs different from thefirst input, the control element 50 will generate a control signal 54that actuates the second delivery mechanism 48. The control element 50will not actuate the first delivery mechanism 46 in response to thesecond prescribed input.

Because the first and second control signals 52 and 54 are generated inresponse to different prescribed input criteria, the medications storedin the two storage compartments 40 and 42 can be selectivelyadministered differently.

As best shown in FIG. 5, the input criteria that generate the first andsecond control signals are derived from both external and internaldevices 55 associated with the medication delivery system 20. Thesedevices receive input from internal memory 26, the physician (orhealthcare professional), and the individual patient.

More particularly, the system 20 includes in internal memory 26 one ormore prescribed schedules for administering medication. Here, theattending physician records the medication regime he or she hasprescribed for the patient.

The system 20 also includes various external input devices for receivingand interpreting prescribed commands either from the patient or from thecentral monitoring facility 28. These external input devices communicatewith the control element 50 through the main CPU 22 (see FIG. 4). Thereceived commands can include one or more specified commands foradministering medication "upon demand".

In the illustrated and preferred embodiment shown in FIGS. 4 and 5, theexternal input devices include a speech recognition system 56 forreceiving and interpreting preselected verbal commands made by thepatient (for example, by using a Texas Instruments Recognition andSpeech Unit Model TI-2245186-001). The external input devices alsoinclude the modem 30 for receiving and interpreting preselected commandsfrom the central facility 28.

In addition, the external input devices preferably include one or moreinput buttons or keys 58 located at a user-convenient place on thehousing 12. The keys 58 allow the patient to manually enter theprescribed medication delivery commands, if desired. In the illustratedand preferred embodiment shown in FIGS. 1 and 2, only a select few inputkeys 58 for entering block (or macro-) commands are provided. Thisarrangement simplifies the patient's interface with the device 10.However, it should be appreciated that a full keyboard could also beincluded, depending upon the degree of sophistication and desires of thepatient.

In the illustrated and preferred embodiment shown in FIGS. 4 and 5, thesystem also includes an external output device associated with the mainCPU 22 for delivering messages or otherwise communicating with thepatient. Preferably, the external output device includes a speechgeneration system 60 for generating audible messages to the user. Thespeech generation system 60 can take the form of either a conventionaldevice that synthesizes speech or a conventional device that digitizesprerecorded speech.

In addition, the external output device also preferably includes a videomonitor 62 on which the audible messages appear in written form (seeFIGS. 1 and 2 also). In this arrangement, the video monitor 62 can alsodisplay in written form the preselected medication administrationcommands. In this way, the video monitor 62 serves to visually back upand confirm the verbal messages and commands being exchanged by thepatient and the device 10, thereby minimizing the chance ofmisunderstandings or failures to communicate.

Due to these various input and output devices, the medication deliverysystem 20 as just described affirmatively interacts with the patient,relying upon both spoken and written forms of communication with thepatient.

SYSTEM FOR STORING AND ADMINISTERING SCHEDULED MEDICATION AND ON DEMANDMEDICATION

In accordance with one aspect of the invention, the control element 50as above described can store and selectively administer one category ofmedication that should be administered only according to a prescribedschedule and another category of medication that can be administeredupon demand by the patient.

The control element 50 associated with this arrangement is showndiagrammatically in FIGS. 6a and 6b. The prescribed medication scheduleis retained in the internal memory 26. The control element 50 includes afirst operative sequence 64 that will generate the first control signal52 upon receiving a valid administer medication command from an internalsource (that is, a command generated internally based upon preprogrammedconsiderations). In the illustrated embodiment, the appropriateadminister medication command is internally issued periodically by theCPU 22, based upon a continuous real time monitoring of the prescribedmedication schedule stored in the internal memory 26.

Upon generation of the first control signal 52, medication retained inthe first storage compartment 40, and only the first storage compartment40, will be released to the patient.

Preferably, the first operative sequence 64 also generates a "CanAdminister" message, using one or more of the output devices (the speechgenerator 60 and/or the display 62), advising the patient that theprescribed medication is being dispensed according to schedule.

The control element 50 also includes a second operative sequence 66that, in association with the external input devices (modem 30/key input58/speech recognition 56), receives and interprets one or moremedication delivery commands received from an external source, such asthe patient or the central facility 28. As shown in FIG. 6a the secondoperative sequence 66 conducts a validity check upon the command. Thesecond operative sequence 66 also checks to determine what type orcategory of medication is being requested.

Upon receipt of a valid command or commands requesting the proper typeof medication, the second operative sequence 66 generates the secondcontrol signal 54. The medication retained in the second storagecompartment 42, but not the first storage compartment 40, is therebyreleased to the patient.

The second operative sequence 66 also preferably communicates anappropriate "Can Administer" message to the patient through one or moreof the output devices 60/62. If the medication request originates fromthe patient, an advisory message may also be sent to the centralfacility 28 via the modem 30 at the time an "on demand" request isreceived and implemented.

If an invalid command is received, or if the patient requests amedication that can only be administered according to an internalcommand from the internal memory, an appropriate "Cannot Dispense"message is display and/or spoken using the output devices 60/62.

Preferably, whenever a decision is made to either dispense medication orwithhold medication, the decision is recorded in internal memory 26 forrecord keeping purposes.

The first delivery mechanism 46 is thereby actuated in response to aninternally generated command signal, but not in response to anexternally generated command signal. The first category of medicationcan thus be safely retained within the first storage compartment 40 awayfrom patient access, except as controlled by the control element 50 (viathe first control signal 52). Strict compliance with the prescribedmedication schedule is assured.

The second delivery mechanism 48 is actuated in response to the secondcontrol signal 54 based upon externally received commands. The secondcategory of "on demand" medication can thus be safely retained in thesecond storage compartment 42 for administration externally controlledby the patient or the central facility 28 by issuing a proper externalcommand.

In the illustrated and preferred embodiment shown in FIG. 6a, thecontrol element 50 also includes a third operative sequence 68 thatmaintains a real time record of "on demand" administrations ofmedication and the elapsed time period between them. The third operativesequence 68 includes timing means 70 for comparing the elapsed timebetween one actuation and the next subsequent actuation command to aprescribed fixed interval. The third operative sequence 68 will, basedupon the output of the timing means 70, prevent the next subsequentactuation of the second delivery mechanism 48, despite the receipt of avalid medication command, when the elapsed time period is less than theprescribed period.

In the illustrated and preferred embodiment, the third operativesequence 68 also informs the patient through an appropriate "CannotAdminister" message via one or more of the output devices 60/62. Inaddition, an advisory message can also be transmitted to the centralfacility 28 via the modem 30. In this way, the system guards againstmismedication or overuse of the "on demand" category of medication.

In accordance with another aspect of the invention, the medicationdelivery system is also adaptable to a situation in which a firstcategory of medication is to be administered only in accordance with aprescribed schedule, while the second category of medication is alsoadministered periodically in accordance with the same or differentprescribed schedule, but can also be administered on demand. The controlelement 50 of this,. arrangement is shown diagrammatically in FIGS. 7]aand 7b. Components shared with the control element 50 shown in FIGS. 6aand 6b are given the same reference numerals.

In this arrangement, the second operative sequence 66 actuates thesecond delivery mechanism 42 in response to either a valid internalsignal from the prescribed schedule stored in the internal memory 26(received via preferred path 72 or alternate path 72A in FIG. 7b), or inresponse to the receipt of a valid prescribed medication deliverycommand from one of the external input devices 30/56/58, as beforedescribed. Again, timing means 70 is preferably provided (with preferredpath 72) to assure that mismedication or overuse does not occur. Theprescribed schedule for the second category of medication can be thesame as for the first category. Or, as shown in FIGS. 7a and b, thedifferent categories of medication have different prescribed schedules.

As before, the second operative sequence 66 also preferably advises thepatient, through one or more of the output devices 60/62, upon therelease of or the refusal to release the requested medication

SYSTEM FOR STORING AND ADMINISTERING MEDICATIONS ACCORDING TO DIFFERENTSCHEDULES

As just briefly discussed, in another aspect of the invention, thecontrol element 50 is also applicable for use when medication is to beadministered according to different prescribed schedules. The controlelement 50 of this arrangement is also shown diagrammatically in FIGS.7a and 7b.

In this arrangement, the first and second prescribed medicationadministration schedules are separately stored in the memory device(designated Schedule A and Schedule B in FIGS. 7a and 7b. The firstoperative sequence 64 of the control element 50 generates the controlsignal 52 to actuate the first delivery mechanism 46 in response to avalid signal based upon the first prescribed schedule (Schedule A), butnot in response to the second prescribed schedule (Schedule B). Thesecond operative sequence 66 responds to a valid signal based upon thesecond prescribed schedule (Schedule B) to generate the control signal54 actuating the second delivery mechanism 48.

SYSTEM FOR STORING AND ADMINISTERING MEDICATION ACCORDING TO PRESENTHEALTH PARAMETERS

In accordance with yet another aspect of the invention, the controlelement 50 is also applicable for use when the different input criteriadiscriminate between one category of medication that can be administeredonly according to the schedule prescribed by the physician and anothercategory of medication that can or should be administered when thethen-existing health parameters of the patient dictate. The controlelement 50 of this arrangement is shown diagrammatically in FIGS. 8a-8c.Components shared with the control elements 50 shown in FIGS. 6a, 6b,7a, and 7b are again given the same reference numerals.

In this arrangement, like the arrangements previously described, theprescribed schedule for administering medication is stored in the memorydevice 26. The first operative sequence 64 responds to this schedule ingenerating the first control signal 52, as previously described andshown in FIGS. 6a, 6b.

Unlike the other arrangements, however, the second operative sequence 66shown in FIG. 8b receives and interprets information indicative ofselected one or more health parameters of the patient The secondoperative sequence 66 compares and correlates this information. If aprescribed correlation exists, indicating an abnormal health parameterthat may respond to medication, the second operative sequence 66generates the second control signal 54 to administer the appropriatemedication through the second delivery mechanism 48.

In the illustrated and preferred arrangement shown in FIG. 8b, thesecond operative sequence 66 collects its information from severaldifferent sources. One input comprises the quantitative measurementsderived from the physical testing system 18. Another input comprisesqualitative information received from the patient through the externalinput devices 56/58. Preferably, the second operative sequence 66affirmatively interacts by prompting the patient, using the externaloutput devices 60/62, to provide the qualitative and quantitativeinformation necessary for the second operative sequence 66 to performits required comparison and correlation sequence.

In the illustrated and preferred arrangement shown in FIG. 8b, thesecond operative sequence 66 itself is prompted into action in one oftwo ways. In one sequence (path 74 in FIG. 8a), an "Administer Test"signal is automatically generated according to a prescribed schedulestored in the main memory 26. This schedule carries out the attendingphysician's orders to periodically check the vital signs of the patient.

In another sequence (paths 76 in FIG. 8a), the "Administer Test" signalis generated in response to an external command issued by the patient orby the central facility 28. For example, the patient can issue aprescribed command by voice (through input 56) or by key input 58indicating a particular physical symptom ("I feel like I have a fever"),or a generalized feeling of discomfort ("I don't feel good").Alternatively, the patient can issue a prescribed command requesting aspecific test ("Check my temperature") or request medication ("Give memy pain pills").

The second operative sequence 66 preferably responds initially byrequiring further information from the patient through a predeterminedsequence of questions designed to isolate the particular physicalparameter of concern. These requests are communicated through the outputdevices 60/62, and the responses are received through the input devices56/58. Once the source of the physical problem is determined, the proper"Administer Test" signal is generated.

However generated, the "Administer Test" signal opens the drawer 38 (asshown in FIG. 2) to make the proper testing device(s) 34/36 availablefor use by the patient. The "Administer Test" signal also prompts thepatient through the output communication devices 60/62 to conduct thedesired test or tests.

In the illustrated embodiment (see FIGS. 10 and 11), the drawer 38 isbiased toward an opened position by a control spring 76 (as shown inFIG. 10). A solenoid controlled locking mechanism 78 normally retainsthe drawer 38 in the closed and locked position (as shown in FIG. 11).An "Open" signal to the solenoid releases the locking mechanism 78 toallow the drawer 38 to open in response to the control spring 76. Othermechanisms can be used to accomplish this or a comparable function.

Referring back to FIG. 8a-8c, the quantitative test results obtained bythe testing system 18 are compared to prescribed norms. If the testresults are within prescribed norms, the second operative sequence 66issues an appropriate "Will Not Dispense Medication" message through theappropriate output devices 60/62. The normal test results are reportedto the patient (via output devices 60/62) and, preferably, to thecentral facility 28 (via the modem 30) as well.

However, if the quantitative test results are not within prescribednorms, the second operative sequence 66 of the control element 50proceeds with its further evaluation, taking into account stilladditional qualitative and quantitative considerations.

For example, should the patient complain of a fever, and thequantitative test results establish an above average temperature, thesecond operative sequence 66 may additionally prompt the patient, usingthe external output devices, with a series of questions relating torecent activities, such as exercise or eating, that may effect bodytemperature. The patient's responses are received and interpretedthrough the external input devices 56/58.

The second operative sequence 66 of the control element 50 compares andcorrelates this qualitative and quantitative information in accordancewith preprogrammed diagnostic routines. If a correlation existsindicating that the patient has a temperature that is unrelated torecent activities, the second operative sequence 66 generates the secondcontrol signal 54 required to activate the second delivery mechanism 48where the prescribed temperature reducing medication is stored.

In this situation, the second operative sequence 66 also preferablecommunicates with the patient with an appropriate "Can DispenseMedication" message (via the display 62 and with output speech device60) and provides an advisory message to the central facility 28 usingthe modem 30.

In the preferred embodiment, the timing means 70 of the third operativesequence 68 is provided, along with the appropriate advisory message, toassure that symptom-specific medication is not administered too often.

If a correlation does not exist, or if a repeat administration is soughtwithin a given time period, the patient is so informed by an appropriate"Will Not Administer Medication" message, and no medication isadministered. However, an advisory message may nevertheless betransmitted to the central facility 28 or to a designated caregiverusing the modem 30.

As shown in FIG. 3, the medication delivery system can separately storeseveral different types of medication to treat different physicalsymptoms, such as high temperature, indigestion, or body pains. Thecontrol element 50 can receive and correlate the qualitative andquantitative information, and, upon arriving at a prescribedcorrelation, generate the specific control signal to administer theappropriate type of medication, depending upon the symptom encountered.

SYSTEM FOR ALTERING PRESCRIBED MEDICATION SCHEDULES FOR REMOTEADMINISTRATION

In accordance with yet another aspect of the invention, the controlelement 50 can further include means for temporarily altering theroutine dictated by a prescribed schedule stored in the internal memory26 in response to a prescribed "Alter Routine" command received fromeither the patient or the central facility 28, or for permanentlychanging the medication administration schedule in response to aprescribed "Change Routine" command received from the central facility28.

A control element 50 that serves this purpose is shown diagrammaticallyin FIG. 9. As before described, the control element 50 includes a firstoperative sequence 64, which bears the same reference numeral assignedbefore. The first operative sequence 64 administers medication inaccordance with an internal signal generated according to a prescribedschedule contained in the main memory 26.

In this embodiment, the control element 50 comprises a fourth operativesequence 80 that alters the prescribed routine upon response to aprescribed "Alter Routine" command. The specific arrangement shown inFIGS. 9a and 9b is based upon a representative situation where thepatient will be away from home when a prescribed medicationadministration event is scheduled to occur. In this situation, thefourth operative sequence 80 serves to administer the medication inadvance of the schedule, so that the patient can take the medicationwith him/her for administration at the prescribed time.

In a preferred arrangement, the fourth operative sequence 80 also servesto attempt affirmatively contact with the patient at his/her remotelocation (via path 84 in FIGS. 9a, 9b) when it is time to take themedication.

In this situation, the prescribed "Alter Routine" command may be issuedeither by the patient or by the central monitoring facility 28,according to the procedure prescribed by the attending physician. Forexample, the physician may order that only the central facility 28 canissue an "Alter Routine" command. In this arrangement, the fourthoperative sequence 80 will not respond to an "Alter Routine" commandissued directly by the patient. The patient would thereby be required torequest an alteration in his/her routine from the physician or personnelat the central facility 28.

Upon receipt of a valid "Alter Routine" command, the fourth operativesequence 80 will, in the preferred arrangement shown in FIGS. 9a, 9b,require the patient to provide a phone number where he/she can bereached at the time the next prescribed medication event occurs. In thisembodiment, the fourth operative sequence 80 will release the medicationonly if the remote contact information is provided by the patient. In analternate arrangement, the fourth operative sequence 80 can releasemedication without requiring remote contact information.

In this arrangement, the fourth operative sequence 80 establishes acheck point 82 within the routine of the first operative sequence 64.The check point 82 determines whether a valid "Alter Routine" commandhas been accepted by the fourth operative sequence 80. If it has, thefirst operative sequence 64 will respond to the prescribed schedule bygenerating a signal (via path 84 in FIGS. 9a, 9b) that does notadminister medication, but attempts to contact the patient at the remotecontact point using the modem 30. If contact is made, a message istransmitted to remind the patient that the prescribed time for takingthe medication has arrived.

In one arrangement, the fourth operative sequence 80 can communicatewith the away-from-home patient through a paging or cellular telephonesystem. Likewise, the patient can remotely communicate with the devicewhen away from home.

In the "Alter Routine" sequence illustrated in FIGS. 9a, 9b, the fourthoperative sequence 80 of the control element 50 does not alter thememory resident schedule itself. The prescribed schedule remains thesame and controls during the next prescribed medication event, unlessanother "Alter Routine" command is accepted.

In the embodiment illustrated in FIGS. 9a, 9b, the control elementincludes a fifth operative sequence 86 to actually change the memoryresident schedule in response to a valid "Change Schedule" command.

The specific arrangement shown in FIGS. 9a, 9b, is based upon arepresentative situation where the attending physician has changed thedrug regime. The central monitoring facility 28 remotely issues a"Change Schedule" command to gain access to and alter the memoryresident schedule. Preferable, a "Change Schedule" command will bereceived and interpreted by the system only with appropriate pass wordprecautions and safeguards.

In the same manner, the attending physician can by issuing a prescribed"Change Category" command to change the administration criteria ofmedication retained by the system. For example, the physicians canremotely make a medication that could be administered "on demand" to a"schedule only" category, and vice versa.

A REPRESENTATIVE PHYSICAL EMBODIMENT

The specific configuration of the interactive medication delivery system20 as above described can vary according to the form in which themedication is administered. For example, one or more types of medicationcan be administered in predetermined dosages in sealed packets or"blister packs". Alternatively, or in combination, single dosages of amedication can be administered in a pill or caplet form, either inunsealed, "loose" form or on sealed rolls.

Attention is directed to FIGS. 1 to 3 and 10 to 16, where arepresentative system 200 for storing and delivering individual pills orcaplets is shown that embodies the features of the invention.

The system 200, is carried within the confines of the patient monitoringand assistance device 10 (see FIGS. 1 to 3). The system 200 includesdiscrete medication storage compartments 202 A through J (see FIG. 3).The storage compartments 202 are each capable of separately storingmedication in pill or caplet form.

In the illustrated embodiment shown in FIG. 3, there are ten storagecompartments 202 located within an enclosed housing. Of course, thenumber of individual compartments can vary according to the needs of thepatient. Each compartment 202 is capable of holding a number ofindividual pills/caplets (designated by reference numeral 44 in FIG. 3).The number of pills/caplets carried within each compartment 202 isdetermined by the physician according to the demands of the particularmedication regime and how often the medication is to be replenished.Typically, a two week supply of medication can be contained within eachcompartment 202.

As shown in FIG. 3, the pills/caplets 44 are arranged side-by-side in aplurality of vertically stacked columns 208 within each compartment 202.As shown in FIG. 3, the compartments 202 preferably differ in overallvertical height and/or transverse thickness. The differing physical sizeof the compartments 202 (particularly in terms of thickness) permits thestorage of pills/caplets of differing sizes. It also assures the properordered arrangement of the compartments 202 within the system 200, aswill be described in greater detail later.

The housing 204 that encloses the compartments 202 is mounted in thedevice 10, behind the drawer 38 that contains the testing devices (seeFIGS. 10 and 11). The housing 204 can be tilted out from back of thedevice 10 for service and to load medication into the system 200 (seeFIG. 2 also).

In the illustrated embodiment, as best seen in FIG. 3, the system 200includes ten separate medication delivery means or mechanisms 206 Athrough J, one associated with each storage compartment 202. Eachmechanism 206 is individually controlled by one of the control elements50 in response to a prescribed control signal or signals in the mannerpreviously described.

Each delivery mechanism 206 is identical in construction, so only onewill be described in detail.

In the illustrated arrangement (as best shown in FIGS. 12 to 15), themedication storage columns 208 are located between a front (right) wall211 and a rear (left) wall 213 formed within the compartment 202. Thelower end 209 of each vertical medication storage column 208 is open.The ends 209 open into a channel 210 that spans the bottom of thecompartment 202. The lower edges 215 of the front and rear walls 211 and213 are closed.

The channel 210 includes an open front end 212 adjacent thecompartment's front wall 211 and an open back end 214 adjacent thecompartment's rear wall 213 (respectively positioned to the right and tothe left in FIGS. 12 to 15). The channel 210 also includes a bottom wall216 and two upstanding sidewalls 218 (see FIG. 3). The channel bottomwall 216 includes a opening 220 adjacent its open back (left) end 214,directly beneath the closed lower edge 215 of the compartment's rearwall 213.

The delivery mechanism includes a shuttle member 222 that is movablewithin the channel 210 between a rearward position, fully within thechannel 210 (shown in FIG. 12), and a forward position, extendingpartially outside the open front end 212 of the channel 210 (shown inFIGS. 3 and 14).

The shuttle member 222 includes an open passageway 224 that registerswith the bottom opening 220 in the channel 210 when the shuttle member222 is in its rearward position (see FIG. 12). Movement of the shuttlemember 222 successively toward the forward position (see FIGS. 13 and14) brings the passageway 224 into sequential registration with the openbottom 209 of each of the storage columns 208.

A linkage assembly couples each shuttle member 222 to an associatedelectric motor 226 to drive the shuttle member 222 laterally forward andbackward within the channel 210. While the construction of the linkageassembly may vary, in the illustrated embodiment, it includes a rotatingcrank 228 coupled to the drive shaft 230 of the associated motor 226. Adouble pivoted link 232 is attached at one end to the crank 228. Theother end of the double pivoted link 232 includes a hook 234 thatattaches to a lip 236 on the end wall of the shuttle member 222.

Rotation of crank 228 thereby imparts forward and rearward pivotalmovement to the shuttle member 222. In particular, as shown in FIGS. 12to 15, one full revolution (360-degrees) of the crank 228 will cycle theshuttle member 222 from its rearward position (FIG. 12) into its forwardposition (FIG. 14) and back to its rearward position (FIG. 15).

As the shuttle member 222 is moved out toward its forward position (seeFIG. 12), the passageway 224 will successively come into and out ofregistry with the bottom 209 of each storage column 208 beginning withthe rearwardmost (farthest left) column. The first bottommostpill/caplet encountered in a column will fall by gravity into the emptypassageway 224. The closed bottom 216 of the channel 210 retains thefallen pill/caplet within the passageway 224 as the shuttle member 222moves into is fully forward position and back toward its rearwardposition (in which the passageway is located beneath the closed loweredge 215 of the compartment's rear wall 213). The presence of theretained pill/caplet prevents another pill/caplet from falling into thepassageway 224. Likewise, the leading top wall portion 238 of theshuttle member 222 and the trailing top portion 240 of the link 232serve to progressively close the bottoms of the other columns as theshuttle member 222 is advanced, preventing additional pills/caplets fromentering the channel 210.

When the shuttle member 222 returns to the rearward position (see FIG.15), the passageway 224 will again register with the bottom channelopening 220. The retained pill/caplet will fall from the passageway 224through the bottom channel opening 220 and then into a delivery chute242 that leads to a medication dispenser 244 at the front of the device10 (see FIG. 3 also).

As shown in FIGS. 1 and 2, the medication dispenser 244 is movablebetween a closed position (FIG. 1) and an opened position (FIG. 2). Aspring 245 (see FIG. 3) normally biases the dispenser 244 toward theopened position, and a solenoid controlled latching mechanism 247 isprovided to lock the dispenser 244 in the closed position. At the timemedication is released into the delivery chute 242, the dispenser 244 islocated in its locked and closed position. Upon delivery of themedication to the dispenser 244, a signal to the latching mechanism 247allows the dispenser 244 to move into its opened position in response tothe bias of the spring 245. The dispensed medication is thereby madeavailable to the patient. Upon taking the medication, the patient closesthe dispenser 244, preferably in response to a prompt generated by thedevice 200.

As in the previously described embodiment, in the illustrated andpreferred embodiment of this system (see FIG. 10), each compartment 202can be individually removed from the housing 204 as a module forreplenishment of the medication when the housing 204 is tilted throughthe back of the device 10. The removable, interchangeable modular designof the compartments 202 simplifies a change in medication brought aboutby a change in the prescribed medication regime.

Again, it is contemplated that the modular compartments 202 will beprepacked by trained medical or pharmacy personnel at a location awayfrom the device 10 and then carried on site.

In the illustrated arrangement shown in FIG. 10, the motors and linkageassemblies remain in the housing 204 upon removal of the compartments202. The hooked end 234 of the pivoted link 232 is readily engaged anddisengaged from the lip 236 of the associated shuttle member 222.

The housing 204 includes slots 250 arranged to receive and retain thecompartments 202 in proper alignment with the associated linkageassembly (see FIG. 16). The slots 250, like the compartments 202, differin size, so that a given compartment 202 will uniquely physically fitinto only a selected one of the slots 250. This assures the desiredordered arrangement of medication within the dispensing system 200.

In the illustrated and preferred embodiment (see FIG. 16), eachcompartment 202 is uniquely identified using machine readable code 252.In the illustrated embodiment, the code 252 is readable by an opticalscanning system 254 associated with each slot. The code 252 containsinformation about the medication carried within the associatedcompartment 202, such as the type of medication, the number of dosagescontained, and the patient's name or prescription number. The scanningsystem 254 reads the code 252 as the compartment 202 is inserted intothe appropriate fitted slot 250.

As shown in FIG. 16, the control element 50 for the dispensing system200 preferably includes a comparator 256 that compares the informationsensed by the scanning system 254 with an expected result carried in themain memory 26. If the sensed information is not the expectedresult--for example, when the medication for the wrong patient is beingaccidentally loaded into the system 200--an appropriate error message isgenerated.

The system 200 thus assures, in fail-safe fashion, the placement of theprescribed medication for administration to the patient.

The system 200 shown in FIGS. 1 to 3 and 10 to 16 includes the separatemedication compartments and ten individually controllable deliverymechanisms, one for each compartment. The system 200 can include any oneof the control elements 50 shown in FIGS. 6 to 9. The selected controlelement 50 serves to individually activate the motors 226 associatedwith each of the compartments 202 by generating different controlsignals in response to different input criteria in the manner previouslydescribed.

For example, if a medication regime requires the administration of threedifferent pills/caplets according to a prescribed schedule, the controlelement 50 associated with the system 200 can simultaneously generate afirst control signal to each of the delivery mechanisms associated withthe particular compartments in which the prescribed pills/caplets arelocated. The three pills/caplets would therefore be dispensedsequentially or at the same time. The control element 50 could dispenseother pills/caplets according to different prescribed schedules, or uponpatient demands, upon the issuance of appropriate control signals to theother delivery mechanisms.

The system 200 shown in FIGS. 1 to 3 and 10 to 16 is thereby capable ofstoring and coordinating the administration of many different categoriesof medication in pill or caplet form in accordance with one or moreprescribed schedules, upon demand, or upon any other selectedadministration criteria.

ASSOCIATED SYSTEM FOR MAINTAINING AND MANAGING A MEDICATION INVENTORY

In accordance with another aspect of the invention, the medicationdelivery system 20 as above described forms a part of an overall system100 that inventories and otherwise manages the medication regime of apatient. This system 100 is shown in FIG. 17. As there shown, theinventory and management system 100 can be maintained in the massstorage system at the central monitoring facility 28, or within on-siteinternal memory 26, or (preferably) at both locations.

The inventory and management system 100 can network the centralmonitoring facility 28 with the medical delivery systems (designated20A, 20B, and 20C in FIG. 17) of a number of patients, therebycentralizing inventory and management control over the medicationregimes of different patients

The inventory management system 100 maintains a log 102A/B/C for eachmedication delivery system 20A/B/C in the network. Each log 102A/B/C ispreferably maintained on site by each delivery system 20A/B/C/ as wellat the central monitoring facility. While the contents of each log102A/B/C will differ, the basic format of each is the same. Therefore,only one (log 102A) will be described.

As shown in FIG. 18, the log 102 includes a separate data file for eachmedication storage compartment in the associated system 20, either insequential or random access format. In FIG. 18, two medication storagecompartments 40 and 42 are shown for illustration purposes (as in FIG.7), and there are thus two associated data files 104 and 106. Each file104 and 106 includes a number of records, which contains the informationnecessary to oversee and manage the administration of the particularmedication stored in the associated compartment. These records aregenerally identified in FIG. 18 as R1, R2, R3, etc.

In the illustrated embodiment, each medication file 104 and 106 includesa first record (R1) 108 that reflects the date and time the medicationwas administered according to the schedule in internal memory 26; asecond record (R2) 110 that reflects the date and time the medicationwas administered on demand; and a third record (R3) 112 that reflectsthe date and time the system 20 refused to administer medication.

Each medication file 104 and 106 also includes a fourth record (R4) 114that contains a number that represents the amount of the medicationpresently remaining within the associated storage compartment 40/42.

Each medication file 104 and 106 can include a number of additionalrecords depending upon the level of detail required. For example, themedication file can include a record that reflects the category of themedication as programmed in the control element 50 (by schedule, ondemand, or both); the minimum dosage interval programmed in the timingmeans 70 (see FIG. 8); the prescribed dosage in terms of time and amountprogramed in internal memory 26; the storage compartment number wherethe medication is located within the delivery system 20; and the date onwhich the storage compartment was last replenished.

The first, second, third, and fourth records 108/110/112/114 are createdand updated based upon signals generated by the associated controlelement 50. In FIG. 18, the control element 50 shown in FIG. 7 iscontemplated.

The generation of the first control signal 52 and accompanying "CanAdminister" message loads date/time data into and updates the firstrecord 108 of both files 104 and 106 (it is assumed that the medicationscontained in compartments 40 and 42 are each administered according tothe schedule).

The generation of the second control signal 54 and accompanying "CanAdminister" message loads date/time data into and updates the secondrecord 110 of the second file 106 (it is assumed that only themedication contained in the second compartment 42 can be administeredupon demand).

The generation of a "Cannot Administer" message loads date/time datainto and updates the third record 112 of each file 104/106.

The fourth record 114 of each file 104/106 is initialized each time themedication in the associated storage compartment 40/42 is replenished onsite, to thereby represent the amount of medication initially placedinside the compartment 40/42. In the illustrated embodiment, it iscontemplated that the person who replenishes the medication on-site willmanually initialize the fourth record 114 through an appropriate entrymade using the input keys 58. Of course, the initialization can bemanually made, via the modem 30, from the central facility 28. Theinitialization could also be accomplished automatically when thecompartment 40/42 is loaded into the system 20, by using the machinereadable code and associated scanning device previously described

Once initialized, the fourth record 114 of each file 104/106 is updatedby reducing the initialized amount by one whenever a first or secondcontrol signal 52 and 54 is generated, as appropriate.

In the illustrated and preferred embodiment (see FIG. 18), the system100 also includes a comparator 116 associated with each medication file04/106. Each time the fourth record 114 is updated and/or at prescribedperiodic time intervals, the comparator 116 compares the number storedin the fourth record 114 with a preselected number stored in the mainmemory 26 that represents a minimum storage amount for that particularstorage compartment. When the number stored in the fourth record 114 isequal to or less than the associated minimum storage amount, a"Replenish" signal is generated to alert the patient and the centralmonitoring facility 28. A person is then sent to replenish themedication contained in the associated compartment 40/42 and toinitialize the fourth record 114.

The system 100 thus continuously monitors the patient's medicationregime and assures that medication sufficient to comply with the regimeis available within the medication delivery system 20.

As shown in FIG. 19, the system 100 preferably also includes a follow upsequence 118 for determining whether medication that is dispensed isactually taken by the patient. In the illustrated embodiment, the followup sequence 118 comprises a loop 120 that, after the medication isdispensed, inquires whether the dispensed medication was taken. Theinquiry is made either through the speech output device 60 or thedisplay 62, or both. The loop 120 will periodically repeat the inquiryunless either an affirmative or negative response is provided by thepatient, either by a voice command or through the input keys.

If an affirmative response is received, the appropriate first or secondrecord 108/110 is updated to reflect that the medication dispensed wasactually taken.

If a negative response is received, the follow up sequence 118 willfirst determine whether the patient accidentally lost the dispensedmedication through an additional series of inquiries by voice and/ordisplay.

The follow up sequence may inquire "Did you lose the medication?" If thepatient's response (by voice or by input key) indicates that themedication was dropped and lost, the appropriate first and second record108/112 is updated to reflect this fact. In this instance, the centralfacility 28 is alerted. The central facility 28 may then investigate andissue the appropriate "Repeat Administration" command to administer arepeat dose of the lost medication. The "Repeat Administration" commandoverrides any associated timing means 80.

If the patient will not respond, the follow up sequence 118 may warn thepatient "If you do not take your medication within three minutes, Ishall notify the central facility" and wait three minutes for anaffirmative response. If the affirmative response is not received, theappropriate first or second record 108/110 is updated accordingly. Thecentral facility 28 is also alerted via the modem 30 that the patienthas failed to take the dispensed medication. The central facility 28will then investigate.

It should be appreciated that all of the medication delivery systemsdescribed in this Specification are applicable for use out ofassociation with a patient monitoring and assistance device. The systemscan be used in virtually any environment where storage and delivery ofselective medications are desired, such as in a hospital, nursing home,or pharmacy. It should also be appreciated that the medication deliverysystems described can be actuated and controlled manually, withoutreliance upon the automated and highly interactive microprocessorcontrolled systems described in this Specification. Furthermore, eachdelivery mechanism and associated storage compartment can be usedindividually as a single unit, as well as in the multiple configurationsshown in this Specification.

The features of the many aspects of the invention are set forth in thefollowing claims.

We claim:
 1. A medication delivery device comprisinga housing, firststorage means for storing at least one dose of a medication within thehousing away from access by the user, second storage means separate fromthe first storage means for storing at least one dose of a medicationwithin the housing away from access by the user, first delivery meansassociated with the first storage means for selectively delivering amedication dose from the first storage means to the user, seconddelivery means associated with the second storage means for selectivelydelivering a medication dose from the second storage means to the user,internal memory means for storing a prescribed schedule foradministering medication, input means including testing means for theuser to measure a preselected physical parameter and means for receivingand interpreting information indicative of the selected physicalparameter measured by the testing means, first control means foractuating the first delivery means in response to the prescribedschedule stored in the internal memory means and not in response to thereceipt of information by the input means, and second control means forcorrelating the measurement by the testing means with a desired resultand for generating a control signal to actuate the second delivery meansonly when a predetermined correlation exists.
 2. A device according toclaim 1wherein the second control means includes timing means forpreventing a second actuation of the second delivery means when the timeperiod between a first and second actuation is less than a prescribedperiod.
 3. A device according to claim 1and further including secondinput means for receiving and interpreting at least one changemedication schedule command from the user, and further including meansfor altering the prescribed schedule stored in the internal memory meansin response to the receipt of a prescribed change medication schedulecommand from the second input means.
 4. A medication delivery devicecomprisinga housing, first storage means for storing at least one doseof a medication within the housing away from access by the user, secondstorage means for storing at least one dose of a medication within thehousing away from access by the user, testing means for the user tomeasure a preselected physical parameter, third storage means separatefrom the first and second storage means for storing the testing meanswithin the housing away from access by the patient, first delivery meansassociated with the first storage means for expelling selectivelydelivering a medication dose from the first storage means to the user,second delivery means associated with the second storage means forselectively delivering a medication dose from the second storage meansto the user, third delivery means associated with the third storagemeans for selectively delivering the testing means from the thirdstorage means to the user, internal memory means for storing aprescribed schedule for administering medication, input means forreceiving and interpreting information indicative of the selectedphysical parameter measured by the user with the testing means, firstcontrol means for actuating the first delivery means in response to theprescribed schedule stored in the internal memory means and not inresponse to the receipt of information by the input means, and secondcontrol means for correlating the measurement taken by the testing meanswith a desired result and for generating a control signal to actuate thesecond delivery means only when a predetermined correlation exists.
 5. Adevice according to claim 4wherein the second control means includestiming means for preventing a second actuation of the second deliverymeans when the time period between a first and second actuation is lessthan a prescribed period.
 6. A device according to claim 4and furtherincluding second input means for receiving and interpreting commandsfrom the user, and further including means for altering the prescribedschedule stored in the internal memory means in response to the receiptof a prescribed change medication schedule command from the second inputmeans.
 7. A device according to claim 4and further including secondinput means for receiving and interpreting commands from the user, andfurther including third control means means for actuating the thirddelivery means in response to the receipt of a prescribed requesttesting command from the second input means.
 8. A device according toclaim 4and further including second internal memory means for storing aprescribed schedule for using the testing means, and further includingthird control means means for actuating the third delivery means inresponse to the schedule stored in the second internal memory means. 9.A device according to claim 8and further including second input meansfor receiving and interpreting commands from the user, and wherein thethird control means also actuates the third delivery means in responseto the receipt of a prescribed request testing command from the secondinput means.
 10. A device according to claim 9wherein the second inputmeans includes speech recognition means for receiving and interpretingat least one prescribed verbal response made by the user.